Kornimate/medical-research-clean huggingface dataset:
comparative pharmacokinetics of two different oral delivery systems of cholecalciferol

Conditions: Vitamin D Deficiency

Summary: the aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of cholecalciferol i.e. ampoules and softgel capsules.

deficiency of vitamin d is highly prevalent in all sectors and regions of pakistan. its effects encompass multiple pluripotent physiological impacts on human body, including its classical action on bone health and immune modulation. health care workers are routinely prescribing supplementations to correct the deficiencies. different forms of cholecalciferol are available in the market. it ranges from absorba liquids, drops, tablets, softgels to injectable and oral ampoules. different delivery systems offer different advantages, challenges and efficacies specific to their specific pharmacokinetics. the aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of cholecalciferol i.e. ampoules and softgel capsules.

Eligibility criteria:
inclusion criteria: 1. adult (20-70 years of age) 2. vitamin d deficiency (serum 25(oh)d \< 20 ng/ml) 3. permanent employees of medicine ward of holy family hospital, dhq, bbh hospitals and rmu for easy follow up throughout the study duration 4. willingness and availability to show-up in the follow up visit and serum testing throughout the study period as needed exclusion criteria: 1. vitamin d sufficiency or moderate deficiency (serum 25(oh)d \> 20 ng/ml) 2. pregnant ladies 3. participants already taking vitamin d supplementation, anti-convulsants, barbiturates or steroids 4. subjects with granulomatous conditions, liver disease, kidney disease, or diabetes

Keywords: vitamin d
clinical performance evaluation of knownow sars-cov-2 test for the detection of covid-19 antigen

Conditions: Covid19

Summary: this is an international, multicentre, non-interventional, observational study to assess the clinical diagnostic performance of a rapid, point of care (poc) covid-19 (sars-cov-2) antigen in vitro diagnostic (ivd), the knownow sars-cov-2 rapid antigen test, using saliva samples when compared to reverse transcription polymerase chain reaction (rt-pcr) as the standard detection of covid-19 infection.

the knownow sars-cov-2 rapid antigen test which uses saliva and is a lateral flow diagnostic device that can detect the sars-cov-2 specific antigens that are present on the surface of the virus. the knownow test is an affordable, user friendly, and point of care device that can be mass produced as part of a multipronged strategy to address the global covid-19 pandemic. a saliva sample is collected from someone with suspected covid-19 and mixed with a running buffer. the mixture is added to the sample pad of the knownow test, from where it migrates through the lateral flow strip. if covid-19 antigens are present, they bind to capture proteins on a test line and are made visible by secondary reagents within the device. the test result is visually assessed after 15-30 minutes and provides a binary positive (two lines) or negative (one line) result. levels of covid-19 antigen differ dependent on disease progression. a visible test line (marked t) indicates the presence of covid-19 antigen in sufficient quantity in the collected sample to be detected. the appearance of the control line (marked c) confirms that the test has been performed correctly.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 years or over (or age of adult consent in some states within the united states). 2. suspected covid-19 infection and / or presenting with at least 1 recognised symptom fever or chills. ie: cough. shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat 3. be willing and able to comply with study procedures. 4. be able to give written informed consent. exclusion criteria: 1. inability to give written informed consent. 2. vaccinated against sars-cov-2 3. adults unable to undertake the requirements of the nasopharyngeal or saliva sample collection for physical or psychological reasons 4. subjects with other significant disease, condition, or at the clinician's discretion.
detecting hypotension by continuous non-invasive arterial pressure monitoring

Conditions: Hypotension

Summary: the purpose of this study is to determine whether continuous non-invasive arterial pressure (cnap) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal comparing with intermittent oscillometric non-invasive arterial pressure (niap)measurement during spinal anaesthesia for cesarean section .

peri-operative hypotension and fluctuation of arterial blood pressure (bp) during spinal anaesthesia are common. hypotension causes maternal side-effects such as unconsciousness, dizziness, nausea, and vomiting. the potential fetal side-effects are caused by a reduction in the uterine blood flow with consequent reduced oxygen supply and acidosis reflected by impaired blood gas analyses and impaired apgar scores. because of the potential harm to the fetus and the dependency of fetal oxygenation on maternal arterial pressure (ap), it has been strongly recommended to closely monitor mother's arterial pressure and to treat hypotension immediately. non-invasive arterial pressure (niap) measurement is a common method for monitoring in clinical. these hypotension episodes probably would be detected with delay by niap measurement on account of its discontinuous. a monitor for continuous non-invasive arterial pressure monitoring (cnaptm monitor 500, cnsystems medizintechnik ag,graz, austria) using the volume-clamped method. it can monitor timely and provide beat-to-beat value of arterial pressure. the purpose of this study is to determine whether continuous non-invasive arterial pressure (cnap) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal.

Eligibility criteria:
inclusion criteria: * scheduled for elective caesarean section with spinal anaesthesia * pregnancy week above 36 exclusion criteria: * age\<18 yr * cardiac arrhythmia * vascular pathologies of the upper limbs (recent vascular surgery, raynaud's disease， vascular stenosis) * contraindication for spinal anaesthesia * emergency case

Keywords: obstetric anesthesia hypotension arterial pressure measurement techniques
drug repurposing using metformin for improving the therapeutic outcome in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: this study aims to evaluate the effect of metformin as add- on therapy for improving the outcome in rrms patients.

multiple sclerosis (ms) is an autoimmune-mediated neurodegenerative disease of the central nervous system characterized by inflammatory demyelination with axonal transection. worldwide, there are about 2.3 million ms patients. women are twice as likely to have ms as men. ms typically presents in young adults (mean age of onset, 20-30 years) and can lead to physical disability, cognitive impairment, and decreased quality of life. the four main types of multiple sclerosis are clinically isolated syndrome (cis), relapsing-remitting ms (rrms), secondary progressive ms (spms), and primary progressive ms (ppms). this research focuses on rrms as it is the most common type (80%- 85%). elevated level of interleukins, and oxidative stress parameters are associated with ms pathology which exaggerated the myelin destruction, axonal degradation, and inflammatory cascade. metformin has a global safety record, is well-tolerated by the majority of patients and is used by roughly 125 million people worldwide, so a lot of studies inside and outside egypt investigates their potential effect in different disorders as neurodegenerative diseases and cancer. despite the prevalence of animal studies which explored metformin neuroprotective effects by decreasing t- helper cells (th 1 and th 17) and improving oligodendrocyte progenitor cell responsiveness to induce remyelination, clinical trials are still insufficient which motivate us to investigate the promising effect of metformin as add-on treatment in rrms patients

Eligibility criteria:
inclusion criteria: * age between 18 and 50 years at time of signing informed consent form. * relapsing- remitting multiple sclerosis as per the mcdonald 2017 criteria, including an mri brain satisfying the 2017 radiological criteria. * full-field visual evoked potential (vep) p100 latency in at least one eye of ≥118 ms. * kurtzke edss step 0.0 - 6.0. * at the time of screening, being treated with a stable dose for at least 6 months of a category 1 multiple sclerosis dmt or for at least 2 years with a category 2 dmt. exclusion criteria: * people taking medication for diabetes mellitus at screening. * female participants who are pregnant, lactating, planning pregnancy, or unwilling to use reliable contraception during the trial. * significant liver impairment; alanine aminotransferase \> 3 times the upper limit of normal. * people suffering from congestive heart failure, chronic lung disease with hypoxia, and severe anemia. * patients with compromised renal function ((egfr \<60 ml/min/1.73m2) or coexistent hypoxic conditions should not be given metformin. * chronic or acute intake of large amounts of alcohol may potentiate the effect of metformin on lactate metabolism. * patients had been prescribed oral, intravenous, and intramuscular corticosteroids for one month prior to study.
evaluation and modification of surgeon ergonomics in the operation room using artificial intelligence analytics

Conditions: Work Related Upper Limb Disorder; Musculoskeletal Pain

Summary: the study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. this includes poor positioning and time spent in poor positioning while working in the operating room. the study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders and whether an education intervention will change ergonomic risk.

the study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. this includes poor positioning and time spent in poor positioning while working in the operating room. the study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders. employing within-subject pre-post design to assess 1) patterns of aggregate risk data from video analysis in the or for resident and attending surgeons over time and for different types of surgical tasks, 2) concurrent reliability assessment of the rapid upper limb assessment and rapid entire body assessment scores calculated from the software and visual analysis, 3) changes in pain data after review of the soter task ergonomic outputs. the feasibility of using the system in the or will also be assessed for open and laparoscopic surgery. the study team will collect data, perform assessments, collect information from self-proctored surveys, and video record surgeon activities in the operating room on 20 surgeons. the video recordings will take measurements to assess risk factors for work-related musculoskeletal disorders. following the fifth surgical case, the study team complete an education intervention by reviewing measurements established in the video recordings and supply a brief presentation on ergonomics for surgeons. a summary of observed body positioning for each subject is provided. post intervention, five additional surgical cases will be observed in the manner of the previous cases to identify change in ergonomic risk.

Eligibility criteria:
inclusion criteria: • any general surgery operative case by a surgeon from the division of acute care surgery. these cases will be conducted in what has been designated as the "acute care surgery or" for the day. exclusion criteria: * any operative case in which the surgical attending or resident has not signed informed consent to record this individual during the case. * any operative case that the surgical attending feels is inappropriate for video recording or when filming could interfere with surgical procedures
application of machine learning based on fnirs in predicting acupuncture's efficacy in treating tinnitus

Conditions: Tinnitus

Summary: this trial aims to use machine learning to analyze fnirs imaging data of specific brain regions of tinnitus patients, thereby constructing a predictive model of the clinical efficacy of acupuncture for snt.

this study will recruit 500 subjects with tinnitus. functional near-infrared spectroscopy (fnirs) will be employed to examine specific brain regions, and the corresponding fnirs imaging data from all detection channels will be extracted. subsequently, the subjects will undergo a course of acupuncture treatment. based on the recovery status of tinnitus at the conclusion of the acupuncture course, all subjects will be categorized into a "good prognosis group" and a "poor prognosis group" according to relevant efficacy criteria. the entire dataset will then be randomly divided into a training set (70%) and a test set (30%) following a 7:3 ratio.

Eligibility criteria:
inclusion criteria: * bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus. * male and female, aged between 18 and 60 years. * right-handed subjects who are able to comply with the study protocol and sign written informed consent. * not participating in other clinical trials concurrently. exclusion criteria: * participants with objective tinnitus. * participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by fnirs. * participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases. * participants have any contraindications for acupuncture (such as a bleeding tendency). * pregnant or lactating women. * participants have received tinnitus treatment with drugs or other therapies in the last four weeks.

Keywords: acupuncture moxibustion tinnitus fnirs machine learning
a disposable device nas to treat obstructive sleep apnea and snoring

Conditions: Obstructive Sleep Apnea; Snoring

Summary: the purpose of this research study is to test a new approach for treating patients with obstructive sleep apnea and/or snoring. the new nasal device, nastent (nas: nasal airway stent), appears to be a useful alternative or additive treatment.

the nasal stent basically helps to splint the soft palate open. subjects have a baseline (diagnostic) sleep study without wearing the device. subjects are then fitted with the device and then subjects wear the device for at least 7 nights during their sleep while at home. subjects then return for a repeat in-laboratory sleep study while wearing the device. the primary outcome is to assess the effectiveness of the device by change in the apnea-hypopnea index (number of sleep-related abnormal breathing events per hour of sleep) while wearing the device compared to baseline.

Eligibility criteria:
inclusion criteria: * adults that are 18 years of age or older who had a prior sleep-study within the past 6 months that confirmed a diagnosis of obstructive sleep apnea, and with body mass index less than 30 kg/m2. exclusion criteria: * children, pregnant women, homeless, economically disadvantaged individuals, and those who are unable to comprehend or understand english, or follow instructions were excluded. persons with body mass index equal or greater than 30 kg/m2 were excluded.
effects of photobiomodulation in children with down syndrome and possible sleep bruxism

Conditions: Sleep Bruxism

Summary: the main characteristic of an individual with trisomy 21 (t21), commonly known as down syndrome (ds), is muscular hypotonia, a characteristic that mainly affects the masticatory and oropharyngeal muscles, resulting in impairments in speech, swallowing, breathing and chewing, in addition to pain, noise and/or degeneration in the temporomandibular joints (tmj), therefore, developing bruxism. the gold standard for the treatment and control of bruxism is the rigid plate, however, there is difficulty in developing treatment in children and adolescents with t21, therefore, photobiomodulation is a non-invasive intervention alternative already consolidated as an excellent option for modulation in muscle tissues. this study sought to evaluate the efficacy and safety of non-invasive intervention with red led clusters for the control of bruxism in children and adolescents diagnosed with down syndrome. the present study is characterized as a pilot study, composed of individuals of both sexes, aged 4 to 17 years old, attended at the uninove integrated health clinic and diagnosed with down syndrome and bruxism. the treatment was carried out in a total of four sessions, one session per week, where in each session the led plates were applied and post-application electromyographic collection was carried out.


Eligibility criteria:
inclusion criteria: * children and adolescents with a diagnosis of down syndrome * four to 17 years of age * bruxism, based on parental reports of the occurrence of grinding the teeth, incisal and/or occlusal tooth wear following the criteria of the american academy of sleep medicine (aasm) and the questionnaire for the evaluation of bruxism validated by serra negra et al. (2014) and a systematic review performed by manfredini et al. (2013). exclusion criteria: * use of muscle relaxant * temporomandibular disorder * undergoing other therapy for bruxism * other associated neurological diseases * cognitive deficit that impedes understanding the evaluations.
immunogenicity and safety of sanofi pasteur's avaxim 80u pediatric vaccine followed by booster dose

Conditions: Hepatitis A

Summary: as per request by the heath authorities, the present clinical study will assess the immunogenicity and safety


Eligibility criteria:
inclusion criteria : inclusion criteria to be checked at the screening visit (sc): 1. toddlers, children and adolescents: sub-group 1: from 12 months to 3 years of age on the day of inclusion sub-group 2: from 4 to 6 years of age on the day of inclusion sub-group 3: from 7 to 9 years of age on the day of inclusion sub-group 4: from 10 to 12 years of age on the day of inclusion sub-group 5: from 13 to 15 years of age on the day of inclusion 2. screening informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only) inclusion criteria to be checked at the inclusion visit (v01): 1. toddlers, children and adolescents: sub-group 1: from 12 months to 3 years of age on the day of inclusion sub-group 2: from 4 to 6 years of age on the day of inclusion sub-group 3: from 7 to 9 years of age on the day of inclusion sub-group 4: from 10 to 12 years of age on the day of inclusion sub-group 5: from 13 to 15 years of age on the day of inclusion 2. inclusion informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only) 3. able to attend all scheduled visits and to comply with all trial procedures 4. subject anti-hav seronegative (igg) according to the screening results (assay performed with local kit) 5. subject hbsag seronegative and alt \<40 iu/l according to the screening results exclusion criteria : exclusion criteria to be checked at the inclusion visit (v01): 1. participation in another clinical trial in the 4 weeks preceding trial vaccination 2. planned participation in another clinical trial during the present trial period 3. congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy 4. systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances 5. chronic illness at a stage that could interfere with trial conduct or completion 6. blood or blood-derived products received in the past 3 months 7. any vaccination in the 4 weeks preceding the trial vaccination 8. any vaccination planned in the 4 weeks following the trial vaccination 9. history of hepatitis a infection (confirmed either clinically or serologically ) 10. previous vaccination against hepatitis a with the trial vaccine or another hepatitis a vaccine 11. thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination 12. history of /current seizures 13. clinical or serological evidence of systemic illness including hepatitis c and hiv 14. febrile (axillary temperature ≥ 37.1°c) or acute illness

Keywords: hepatitis a
transplantation of autologous bone marrow derived stem cells in patients with rheumatoid arthritis

Conditions: RheumatoId Arthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. rheumatoid arthritis ultimately results in the destruction of cartilage, bone and ligaments and joint deformity. the underlying hypothesis is that autologous bone marrow-derived mesenchymal and specific populations of stem cells has anti-inflammatory and regenerative effects and thus potentially alleviates the progression of rheumatoid arthritis. the study is to explore the safety and efficacy of bm-sc transplantation in treatment of rheumatoid arthritis.

rheumatoid arthritis (ra) is a chronic autoimmune disorder that primarily affects joints. it typically results in swollen and painful joints. pain and stiffness often worsen after rest. most frequently, the wrist and hands are involved, with the same joints typically involved on both sides of the body. ra affects between 0.5-1% of adults in the developed world with between 5-50 per 100,000 people newly developing the disease each year. onset is most frequent during middle age and women are affected 2.5 times as frequently as men. the goal of treatment is to reduce pain, decrease inflammation, and improve a person's overall functioning and quality of life. herein, the investigators study the safety and efficacy of the immunomodulatory effects of bone marrow-derived stem cells administered intravenously and the regenerative and repair potential of bone marrow-derived stem cells transplanted into the joints of patients with ra.

Eligibility criteria:
inclusion criteria: * 17-75 years old * the presence of osteoarthritis based on mri and american rheumatism association criteria since 6 months before treatment. exclusion criteria: * subjects with addition major health condition/disease diagnoses * subjects that are pregnant or breastfeeding

Keywords: stem cells rheumatoid arthritis